FDA 483 - nexAir LLC - January 12, 2024

An FDA inspection of nexAir LLC in Okeechobee, FL, a medical gas manufacturer, identified significant shortcomings in its quality control unit. The firm's written procedures for critical operations like filling, quarantine, annual product reviews, and label storage were either not fully followed or contained conflicting information. These deficiencies indicate a need for improved adherence to and clarity in quality system processes.